Slotted Hole Versus Fixed Hole C-Tek

Stopped early · Not applicable

Conditions studied: Herniated Disc, Radiculopathy, Spondylolysis

In brief

The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.

Key facts

Study ID

NCT00585923

Run by

Zimmer Biomet

People needed

115

Starts

2002-04-01

Expected to finish

2008-05-01

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Radiographic evidence of compressed cervical roots or cord by either ossified bony elements or herniated nucleus pulposus.
• Symptomatic radiculopathy appropriate to compressed nerve root.
• Cervical spondylosis as evidenced by reactive changes in the vertebral bodies about the interspace, and may be associated with chronic discopathy.
• Primary anterior cervical spinal fusion (ACDF) performed using an anterior cervical plate and either a discectomy (Smith-Robinson technique) or a Corpectomy.
• Adult male or female, 18 to 75 years of age.
• The subject or his/her legal guardian is willing to consent to participate in this study.
• The subject will be available for follow-up for a minimum of 24 months.

You may not qualify if…

• Traumatic cervical injury.
• Posterior augmentation or revision fusion.
• Cervical fusion involving C1 and C2 vertebrae.
• Cervical fusion involving more than three levels.
• Previous spine surgery at the same levels as those that will be fixed with the C-Tek plate.
• Systemic conditions: Spondylitis, Paget's disease, Rheumatoid arthritis, Infection within two weeks before surgery, Cancer, Renal disease or insufficiency with creatinine level above 2, Chronic use of steroids or other conditions that may affect bone metabolism
• Subjects who are pregnant, nursing or plan to be pregnant within the next 24 months.
• Mental or physical conditions that may preclude compliance with physician instruction or the study protocol.
• Subjects who require non-steroidal medications chronically for other conditions.
• Subject declines to cooperate with the follow-up schedule.
• Subject or legal guardian refuses or is unable to sign the informed consent.

Where it is running

• Spine Institute of Louisiana — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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